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News

Only four months after it was carved out from Sanofi to become an independent company, Prague-based Zentiva has announced fresh leadership in the form of Nick Haggar, the 30-year industry veteran and former president of Medicines of Europe.

News

With an eye on moving to market its broad pipeline of innovative brands, Pfizer has cut development of five early-stage biosimilar assets, in a decision that will affect 150 staff. The move is not reflective of Pfizer's overall commitment to biosimilars, the US-based company maintains.

News

A strengthened cash position has provided Amneal the chance to seek inorganic opportunities to bolster its growing presence in injectables. The US-based, US-centric company is looking to grow its operations, having been surprised in recent weeks by generic competition to its most lucrative generic assets.

Interviews

By the middle of this year, biosimilars developer Alvotech plans to have strategic alliances in place with a handful of regional partners to commercialize its pipeline of seven biosimilar monoclonal antibodies.

News

Under plans announced last December, Mallinckrodt is to spin off its specialty generics and API business; at the recent Annual J.P. Morgan Healthcare Conference, management painted a timeline to completing the project and provided details on the business’ financing and growth prospects.

News

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

News

Dr Reddy’s is hit with a manufacturing setback after getting issued a Form 483 report for its site in Andhra Pradesh, India, while several firms announce site expansions, including in Spain and the US.

News

Krka is keen to expand its geographic presence beyond its stronghold
in Europe, especially by capitalising on the “huge opportunity” in
China. But it has no immediate plans to build a major presence in
the Americas, according to the Slovenian group’s management board
member David Bratoz.

News

Sun’s managing director, Dilip Shanghvi, has defended the
“underlying health” of the company after a sizeable charge linked
to antitrust litigation almost completely wiped out Sun’s pre-tax profit
in its financial second quarter, while a sales decline in India limited
overall turnover growth.

News

Nichi-Iko has started promoting the value-added portfolio of Eisai’s
Elmed in Japan under a strategic alliance struck earlier this year
that also includes Nichi-Iko acquiring all shares in Elmed by 1 April
2019. As part of the “phased acquisition” (Generics bulletin, 6 April
2018, page 3), Nichi-Iko said it had by 1 October acquired a third of
stocks in Elmed for a total of ¥5.47 billion (US$48.7 million).

News

Only four months after it was carved out from Sanofi to become an independent company, Prague-based Zentiva has announced fresh leadership in the form of Nick Haggar, the 30-year industry veteran and former president of Medicines of Europe.

News

A month after a court ruled that Fresenius Kabi’s decision to terminate its merger with Akorn was legal and proper, Akorn’s COO has agreed to resign the position, six days after Doug Boothe officially replaced Raj Rai as Akorn’s new president and CEO.

News

The California-based biosimilars player has come good on its promise to introduce early in the new year its first biosimilar in the US and the second biosimilar of Amgen’s Neulasta blockbuster; at the same time, biotech veteran Darlene Horton has joined Coherus’ management team.